Meal Composition for Healthy Habits and Diet

Overseen By Hollie Raynor, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Tennessee, Knoxville

Must not be taking: Appetite suppressants

Disqualifiers: Binge eating, Allergies, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

62 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial excludes participants who are taking medications that affect appetite, so you may need to stop such medications to participate.

What data supports the effectiveness of the treatment Order 1, Order 2, Order 3, Order 4 in the clinical trial 'Meal Composition for Healthy Habits and Diet'?

Research shows that improving meal services, like using a room service program, can significantly increase patient meal consumption and satisfaction. Additionally, protein-enriched menus combined with personalized dietary advice have been found to boost energy and protein intake in patients at nutritional risk. ^{1 2 3 4 5}

Is the meal composition treatment generally safe for humans?

There is some safety data on dietary supplements, which are similar to meal composition treatments. Reports suggest that adverse events (unwanted effects) are not uncommon, but they are often underreported. One study found a possible link between dietary fiber and vomiting, but more research is needed to confirm this. ^{6 7 8 9 10}

How does the treatment in the 'Meal Composition for Healthy Habits and Diet' trial differ from other treatments for weight management?

This treatment focuses on the composition and regularity of meals, particularly breakfast, to improve weight management. Unlike other treatments that may involve medication or supplements, this approach emphasizes dietary habits, such as consuming a protein-rich breakfast, which can enhance appetite control and energy expenditure. ^{11 12 13 14 15}

What is the purpose of this trial?

For weight loss to occur, energy intake needs to be reduced to incur an energy deficit. One dietary strategy that may facilitate weight loss is consuming a diet low in dietary energy density (ED). It is hypothesized that a diet low in ED, which can be achieved by a high intake of low-ED foods, low intake of high-ED foods, or a combination of the two, will allow a greater amount of volume of food to be consumed relative to energy consumed, which can assist with reducing energy intake. To understand how best to lower the ED of the diet, it is important to understand the relationship between low-ED and high-ED foods. Behavioral economics is a framework that provides a foundation to understand that eating behaviors can be substitutes for each other. Substitute eating behaviors are two behaviors that change in the opposite direction of each other (i.e. one behavior increases as the other behavior decreases). If low-ED and high-ED foods are substitutes for each other, in situations in which low-ED food intake increases, high-ED food should automatically decrease, and vice versa. If they are not substitutes, when low-ED food intake increases, high-ED food intake should remain unchanged, and when high-ED food intake decreases, low-ED food intake should remain unchanged. When low-Ed and high-ED foods are not substitutes for each other, purposeful change in intake for both low- and high-ED foods need to occur to best lower dietary ED. Thus, the purpose of this study is to investigate if low-ED foods and high-ED foods substitute for each other. Healthy weight adults will be served a meal over 4 sessions, with each meal containing 5 different food items. The foods in the meal will vary in ED: low-ED = 0 to 1.0 kcal/kg; medium-ED = 1.1 to 2.9 kcal/kg; high-ED = \> 3.0 kcal/g. For the 4 sessions, the meals will include: 1) 3 low-ED foods, 0 medium-ED foods, 2 high-ED foods; 2) 3 low-ED foods, 1 medium-ED food, 1 high-ED food; 3) 1 low-ED food, 2-medium ED foods, 2 high-ED foods; and 4) 1 low-ED food, 3 medium-ED foods, and 1 high-ED food.

Research Team

Hollie Raynor, PhD

Principal Investigator

University of Tennessee

Eligibility Criteria

This study is for healthy adults aged 18-35 with a BMI of 18.5 to 24.9 who enjoy a variety of foods like soup, pudding, and snacks, eat breakfast before 10 am, are not on appetite-affecting meds or have eating-related medical conditions, and can finish the sessions in under 8 weeks.

Inclusion Criteria

I can attend all sessions within 8 weeks after the screening.

You need to rate all of these foods and snacks as at least 50mm on a scale to be eligible: chicken or tomato soup, chocolate sugar-free pudding, grapes, blueberry yogurt, macaroni and cheese, vanilla ice cream, pretzels, and honey graham snacks.

Body mass index (BMI) 18.5 to 24.9 kg/m2

Exclusion Criteria

You have allergies to the foods being tested in the study.

I am on medication that changes my appetite.

You have a medical condition that affects your ability to eat.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 session (60 minutes)

1 visit (in-person)

Meal Sessions

Participants attend 4 meal sessions to evaluate energy intake and food liking

2 weeks

4 visits (in-person)

Follow-up

Participants are monitored for any changes in eating behavior and overall satisfaction

1 week

Treatment Details

Interventions

• Order 1
• Order 2
• Order 3
• Order 4

Trial Overview The trial tests if low-energy-density (low-ED) foods can replace high-energy-density (high-ED) ones in meals to help with weight loss. Participants will eat meals with varying ED levels over four sessions to see how their food intake adjusts.

Participant Groups

Group I: Order 4 Experimental Treatment 1 Intervention

Meal 4, Meal 1, Meal 2, Meal 3

Group II: Order 3 Experimental Treatment 1 Intervention

Meal 3, Meal 4, Meal 1, Meal 2

Group III: Order 2 Experimental Treatment 1 Intervention

Meal 2, Meal 3, Meal 4, Meal 1

Group IV: Order 1 Experimental Treatment 1 Intervention

Meal 1, Meal 2, Meal 3, Meal 4

Who Is Running the Clinical Trial?

The University of Tennessee, Knoxville

Lead Sponsor

Trials

93

Recruited

19,500+

Findings from Research

The novel FoodforCare meal service significantly improved protein and energy intake among patients compared to the traditional meal service, with notable increases in intake on both the first and fourth days of full oral intake.

Patient satisfaction with the meal service remained stable, but the FoodforCare group reported better satisfaction regarding the appearance and smell of the meals, indicating a positive reception of the new service.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A novel in-hospital meal service improves protein and energy intake]. Dijxhoorn, DN., van den Berg, MGA., Drenth, JPH., et al.[2018]

In a study of hospitalized patients at nutrition risk, combining a protein-enriched menu with individualized dietary counseling led to 92% of patients meeting over 75% of their energy requirements, compared to 76% in the historical intervention group.

The intervention group also showed a significant increase in mean energy and protein intake, with 31 kcal/kg and 1.2 g protein/kg, respectively, indicating that this combined approach is more effective than using a protein-enriched menu alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From Evidence to Clinical Practice: Positive Effect of Implementing a Protein-Enriched Hospital Menu in Conjunction With Individualized Dietary Counseling. Munk, T., Bruun, N., Nielsen, MA., et al.[2018]

Implementing a co-designed mealtime assistance process in a 31-bed ward led to a significant reduction in wasted meals from an average of 3 per day to 0, which also decreased food waste by 0.43 kg per patient daily.

Patients who received mealtime assistance showed no new incidences of aspiration pneumonia or swallowing difficulties, indicating that the intervention not only improved meal access but also enhanced patient safety and nutritional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing risk of development or exacerbation of nutritional deficits by optimizing patient access to mealtime assistance. Teeling, SP., Coetzee, H., Phillips, M., et al.[2020]

Dietary counseling, with or without oral nutrition supplementation, does not significantly reduce 30-day mortality in hospitalized malnourished adults but may slightly reduce 6-month mortality and complications, based on a meta-analysis of 16 studies.

The evidence suggests that dietary counseling can improve nutrition status and may reduce hospital readmission rates, although the certainty of these findings varies and further research is needed to standardize counseling methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of dietary counseling with or without nutrition supplementation in hospitalized patients who are malnourished or at risk of malnutrition: A systematic review and meta-analysis. Wong, A., Huang, Y., Sowa, PM., et al.[2022]

The Korea Food & Drug Administration (KFDA) established an adverse event (AE) monitoring system for dietary supplements, collecting 1430 AE reports from 2006 to 2008, with 222 providing complete case details for analysis.

The monitoring identified a potential signal linking dietary fiber to vomiting, but due to insufficient data, the KFDA could not confirm a causal relationship, indicating the need for further investigation into this concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The state of adverse event reporting and signal generation of dietary supplements in Korea. Park, KS., Kwon, O.[2010]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

[A novel in-hospital meal service improves protein and energy intake]. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

From Evidence to Clinical Practice: Positive Effect of Implementing a Protein-Enriched Hospital Menu in Conjunction With Individualized Dietary Counseling. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Reducing risk of development or exacerbation of nutritional deficits by optimizing patient access to mealtime assistance. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Improving patient meal satisfaction with room service meal delivery. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of dietary counseling with or without nutrition supplementation in hospitalized patients who are malnourished or at risk of malnutrition: A systematic review and meta-analysis. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The state of adverse event reporting and signal generation of dietary supplements in Korea. [2010]

7. United States pubmed.ncbi.nlm.nih.gov

Taking Stock of Dietary Supplements' Harmful Effects on Children, Adolescents, and Young Adults. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

FDA regulation of dietary supplements and requirements regarding adverse event reporting. [2010]

9. Japan pubmed.ncbi.nlm.nih.gov

[Evaluation of Safety Information of the Foods with Function Claims Based on Adverse Event Reports in Information System on Safety and Effectiveness for Health Foods Database]. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Dietary Supplements: Knowledge and Adverse Event Reporting Practices of Department of Defense Health Care Providers. [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

Breakfast consumption pattern and its association with overweight and obesity among university students: a population-based study. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Nutritive value of meals, dietary habits and nutritive status in Croatian university students according to gender. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Day-to-day regularity in breakfast consumption is associated with weight status in a prospective cohort of women. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

A Review of the Evidence Surrounding the Effects of Breakfast Consumption on Mechanisms of Weight Management. [2023]

15. England pubmed.ncbi.nlm.nih.gov

Association between breakfast frequency and metabolic syndrome among young adults in South Korea. [2023]